Chong Kun Dang announced on Nov. 6 that it has entered into a technology export agreement with Novartis worth US$1.305 billion for its new drug candidate CKD-510.
Under the agreement, Novartis obtains exclusive rights outside of South Korea for the development and commercialization of CKD-510, a low-molecular compound histone deacetylase 6 (HDAC6) inhibitor that is being developed by Chong Kun Dang.
Chong Kun Dang will receive an upfront payment of US$80 million and is set to receive milestone payments up to US$1.225 billion dependent on development and regulatory approvals, as well as sales royalties.
CKD-510 is a highly selective non-hydroxamic acid (NHA) platform technology-based HDAC6 inhibitor. Preclinical studies have demonstrated its efficacy in various HDAC6-related diseases, including cardiovascular conditions. The drug has also proven its safety and tolerability in Phase 1 clinical trials conducted in Europe and the United States.
Animal testing has shown the drug to be effective in treating several diseases related to HDAC6, including cardiovascular diseases. Phase 1 clinical trials began in France in 2019, and in June of the previous year, clinical trials in the U.S. were conducted to switch the drug’s formulation from capsules to tablets. These trials in France and the U.S. confirmed the drug’s safety.
Originally developed as a treatment for Charcot-Marie-Tooth disease, a rare condition with approximately 2.8 million patients worldwide, CKD-510 holds significant market potential as there are currently no developed treatments for this disease, leaving many patients in distress. The drug received Orphan Drug Designation from the Food and Drug Administration (FDA) in March 2020.
CKD-510 also has the potential to be developed into a more diverse range of treatments. According to the company, the drug has shown effectiveness for a variety of diseases beyond Charcot-Marie-Tooth during clinical trials.
Kim Young-ju, CEO of Chong Kun Dang, said, “Chong Kun Dang has experience in exporting technologies abroad, such as the anemia treatment biosimilar CKD-11101 to Japan and the diabetes drug Duvie to the U.S. This agreement is the largest of its kind to date and represents a rewarding milestone for Chong Kun Dang, which consistently invests more than 12% of its annual sales in research and development. We are proud to export one of our innovative drug candidates developed through these investments to a multinational company and are grateful to our researchers.”